Manuela Leitner - European Medicines Agency

Curriculum vitae
PERSONAL INFORMATION
Manuela Leitner
WORK EXPERIENCE
April 2010–Present
Quality Assessor
AGES Austrian Medicines and Medical Devices Agency, (Austria)
Plasma derived medicinal products, Plasma Master File, biotechnologically derived recombinant
products; preclinical assessment
April 2006–April 2010
Vice Head of Department for Biological Chemical Analysis
AGES Austrian Medicines and Medical Devices Agency, (Austria)
Official control authority batch release of plasma derived medicinal products
Participation in international cooperations (e.g. EDQM, NIBSC, PEI) for establishment of working
standard preparations of coagulation factors, WHO Standard preparations, FEIBA Standard
preparation
August 2004–April 2006
Key Account Manager
CoaChrom Diagnostica, (Austria)
Coagulation and Fibrinolysis , Endotoxins
August 2002–August 2004
Drug Safety Officer
Wyeth Whitehall Export GmbH, (Austria)
Pharmacovigilance
May 2001–May 2002
Scientific Assistant at Institute of Histology and Embryology
University of Veterinary Medicine Vienna, (Austria)
October 1999–March 2001
Scientific Assistant at Clinic for Obstetrics, Gynaecology and Andrology
University of Veterinary Medicine Vienna, (Austria)
EDUCATION AND TRAINING
October 1999–April 2001
Doctor of Veterinary Medicine
University of Veterinary Medicine Vienna, Clinic for Obstetrics, Gynaecology and Andrology, (Austria)
Doctoral Thesis
October 1991–October 1999
Master of Veterinary Medicine
University of Veterinary Medicine Vienna, (Austria)
ADDITIONAL INFORMATION
Expertise
Laboratory experience: Plasma derived medicinal products, Histology
Quality assessment: Plasma derived medicinal products, Plasma Master File, veterinary Vaccines
Publications
19/10/15
Factor VIII Bypassing Activity (FEIBA) assays: standardization and development of the 1st NIBSC
Working Standard for FEIBA--results from a collaborative study.
© European Union, 2002-2015 | http://europass.cedefop.europa.eu
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Curriculum vitae
Manuela Leitner
Raut S, Daniels S, Gärtner P, Hunfeld A, Leitner M, Hockley J, Heath A.
Haemophilia. 2013 Mar;19(2):304-9. doi: 10.1111/hae.12036. Epub 2012 Nov 23.
Humanplasma als Arzneimittel – Teil I
M. Leitner
GMP Journal, Ausgabe 26, Januar/Februar 2013
Humanplasma als Arzneimittel – Teil II
M. Leitner
GMP Journal, Ausgabe 26, April/Mai 2013, pp.13-15
Lectin Binding Patterns in the Canine Endometrium
(Poster)
Leitner, M., Walter, I., Aurich, C., Aurich, J.E.
38. International Symposium Progress in Basic, Applied and Diagnostic Histochemistry., Bratislava,
Slowakei, Oktober 2001, 36.
Nachweis von Glykokonjugaten im Endometrium von gesunden und am HGCE/Pyometra-Komplex
erkrankten Hündinnen
Dissertationsschrift; Rigorosum am 29. April 2002
Endometrial Glycoconjugate Patterns in Bitches with Cystic Endometrial Hyperplasia/Pyometra.
Leitner, M., Galabova, G., Egerbacher, M., Aurich, C., Walter, I., Aurich, J.E.
3rd EVSSAR European Congress on Reproduction in Companion, Exotic and Laboratory Animals.,
Liege, Belgium, 10.-12. Mai 2002, 137-138.
Degenerative Changes of the Canine Endometrium during the Luteal Phase and Anoestrus.
Galabova, G., Egerbacher, M., Leitner, M., Aurich, C., Walter, I., Aurich, J.E.
3rd EVSSAR European Congress on Reproduction in Companion, Exotic and Laboratory Animals.,
Liege, Belgium, 10.-12. Mai 2002, 101.
Cyclic Epithelial Changes in the Endometrium of the Bitch
Galabova, G., Leitner, M., Egerbacher, M., Aurich, J.E., Walter, I.
XXIVth Congress of the European Association of Veterinary Anatomists.,
Czech Republic, Brno, 21.-25. Juli 2002, 109.
Lectin Binding Patterns in Normal Canine Endometrium and in Bitches with Pyometra and Cystic
Endometrial Hyperplasia.
Leitner, M., Aurich, J.E., Galabova, G., Aurich, C., Walter, I.
Histology and Histopathology, 2003, Vol. 18, pp. 787-795
Morphological Changes of the Endometrial Epithelium in the Bitch during Metoestrus and Anoestrus.
Galabova, G., Egerbacher, M., Aurich, J.E., Leitner, M., Walter, I.
Reproduction in Domestic Animals, 2003, Vol. 38, pp. 415-420.
Cyclic Epithelial Changes in the Endometrium of the Bitch.
Galabova, G., Leitner, M., Egerbacher, M., Aurich, J.E., Walter, I.
Acta Veterinaria, 2003, Vol. 72 (Suppl. 7), p. 21.
ARCEM – Austrian Research Cooperation on Endocrine Modulators
Bioindikation. Untersuchungen an Fischen
Grillitsch, B., Gemeiner, M., Gleiß, A., Kuchar, A., Leitner, M., Miller, I., Möstl, E., Schabuss, M.,
Schober, U., Tschulenk, W., Walter, I.
In: UBA (Hrsg.) Hormonwirksame Stoffe in Österreichs Gewässern – Ein Risiko?
Federal Environmental Agency, Austria, Vienna, 2003, pp. 1-132
Projects
Memberships
19/10/15
© European Union, 2002-2015 | http://europass.cedefop.europa.eu
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Curriculum vitae
Other Relevant Information
19/10/15
Manuela Leitner
TSE-CEP Assessor at EDQM
© European Union, 2002-2015 | http://europass.cedefop.europa.eu
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